The FDA was established to ensure the safety of food and medicines sold in the US. Sadly, the original charter is now slowly being affected by the advocates of drug importation, who overlook legitimate safety concerns. Ensuring access to reliable and safe prescription drugs is a paramount concern to drug manufactures in the US. And a majority of Americans including law enforcement officials and pharmacists strive to prevent adulterated or counterfeit foreign medicines from flooding their communities.
The debate on drug importation has been ongoing for decades. People who support it have never created a responsible plan that provides the same level of safety and effectiveness as delivered by the FDA. The agency’s rigorous systems of protocols and rules ensure that prescription medications in the country are effective and safe. This long-established policy has led to protests from those who want people in the country to have easy access to cost-effective drugs.
Faced with the rising costs of drugs, millions of law-abiding Americans buy drugs outside the US even though the practice is generally considered illegal. It’s no secret that US citizens regularly purchase prescription medicines online or while travelling abroad. 80% of respondents in the Kaiser Health Tracking Poll dated November 2016, said that they or someone in their household had at some point imported a drug.
Role of the FDA in Drug Importation
The FDA has faced its share of controversy ever since its inception as an official government agency assigned with the regulation and approval from beef to pharmaceuticals. A recent controversy relates to whether the agency should regulate or ban drug importation to the US. The FDA regulates the ability of pharmaceutical companies in the US to roll out drugs in the market. The argument for regulation of drug importation is generally based on economics, while the bickering against a total ban is in the interest of individual rights.
The FDA prohibits the interstate shipment of unapproved new drugs under the Federal Food, Drug, and Cosmetic Act (FFDCA). Thus, the importation of drugs that lack FDA approval violates the Act. However, if a patient has started treatment with an unapproved drug in another country, or suffers from a condition for which there does not exists any FDA-approved treatment, refraining from taking action against importation may be appropriate, according to the agency’s website.
Who Supplies Drugs to the US?
Nearly 75% of US spending on drugs is for products manufactured within the country. The expiration dates on drugs indicates it pays to be closer to the end consumer. Being close to the FDA in a tightly controlled industry doesn’t harm either. Yet, the sheer size of the US market, which is the biggest in the world, makes it the top importer of drugs on the planet, with $86 billion worth of medicine imported in 2015. The value of imports has shot up by about 200% since 2005.
The top 5 sources of US pharmaceutical imports in 2015 were the UK, Germany, Ireland, Switzerland and India. Excluding India, it’s not possible to find cheap labor in the other countries. Despite this, the UK, Switzerland and Germany are home to some of the globe’s largest research-based pharmaceutical firms. Switzerland and Germany are also popular hubs to the two biggest contract manufactures for biological drugs. Though most medicines are chemically synthesized, biologics are made from animal, human or micro-organism sources and need high tech equipments and a great deal of practical knowledge, skill and expertise.
Ireland is also another source of US drugs imports, accounting for $25 billion of drugs in 2015. The country is home to 24 of the world’s top biotech and pharma companies. The nation’s tax policies have proved so lucrative to medical device and drug companies that the likes of Shire, Medtronic and Allergan have made Dublin their lawful address.
India has a different story from other nations in the list. Instead of manufacturing tiny volumes of exorbitant, innovative drugs, the country focuses on huge volumes of cost-effective generics. With manufacturing costs in India being 50% lower than in other developed nations, the country has become the world’s biggest exporter of generics. The US bought nearly $70 billion of generics in 2015, and that’s slated to grow as more drugs go off patent.
Why is Drug Importation Risky for Patients?
According to a latest report by the WHO, 10% of drugs worldwide and approximately 50% consumed in developing nations are counterfeit. In the absence of FDA’s oversight and proper enforcement of laws developed for patient safety, which is undermined by drug importation, these products could easily infiltrate the pharmaceutical supply chain in the country, with life-threatening consequences. The FDA has repeatedly stressed that it cannot ensure the safety of imported drugs.
Importation is often seen as a ploy to reduce drug costs; however, such proposals disregard important facts on how importation can impact patient safety and provide access to new innovative treatments.
Here are four important factors to consider:
- So far no one in the US Department of Health and Human Services (HHS) has been able to ascertain the fact that importation will not result in public safety and health, and achieve cost-savings that will be passed on to consumers. On February 26, 2003 the Secretary announced the creation of the Task Force on Drug Importation to address the questions posed by the Congress in the Medicare Modernization Act of 2003. The task force was entailed to report to the Congress on how safe the imported drugs are. This act allows drug importation from Canada but only after certification from the Secretary to Congress that these imports will not compromise with the health and safety of the public and will result in cost savings for the consumer. The federal government has however, failed to abide by that to date.
- Foreign governments do not regulate and monitor drugs intended for the US market. The Canadian government, for instance, regulates drugs manufactured for its citizens, but doesn’t ensure safety of drugs shipped through Canada to the US or other nations. There is evidence which shows that some drugs that are shipped to the US from Canada have their origins in other countries with amenable regulatory systems like Pakistan and Bulgaria. A recent evaluation by the FDA exposed that while nearly 50% of imported drugs claimed to be from Canadian pharmacies, a staggering 85% of drugs were from other countries. Also, since imported drugs lack oversight by health authorities, there is a high possibility for the drugs to be mishandled. For example, in some cases, proper temperature is not maintained and causes rotting.
- There is no system in place which ensures potential savings as a result of drug importation being passed on to consumers.
- Counterfeiters are getting heavily sophisticated with their technology and are of grave concern in the health and safety of patients. It has become a cakewalk for counterfeiters to make packages and bottles look authentic, but the fact is they are often filled with fake or adulterated pills. In 2015, a Canadian online pharmacy was fined $78 million for conspiring to allegedly smuggle unapproved and mislabeled prescription drugs into the US. Again in June 2015, the FDA and Interpol seized faked drugs from 1000 websites.
According to The Alliance for Safe Online Pharmacies, there are 30,000 illegal online pharmacies at any given time who do not comply with laws and pharmacy standards.
Illegal and counterfeit drugs kill many Americans every year. The existing counterfeit problem could be scaled up one-hundred fold if proper systems are not put into place. The US is in the grip of the most severe drug epidemic ever since crack cocaine swept major cities in the 1980s. But American consumers deserve much more than drug importation. The need of the hour lies in providing genuine solutions-balanced conversations on health care affordability and that cannot be found in the limited stock shelves of foreign wholesale pharmacies.Copyright © DrugPatentWatch. Originally published at Is importing drugs a risky affair?
Also published on Medium.